Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching

Project Title Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching
Date Posted
Monday, November 6, 2017
Project ID
TO07_MPR_WP02_V01
Status
Complete
Deliverables
Mini-Sentinel Modular Program Report: Niacin and Fenofibrate Use
Related Links
Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System
Niacin and Niacin Combination Products, Fenofibrates, and Omega-3 Products
Concomitant Use of Niacin and Statins and Concomitant Use of Fenofibrates and Statins
Description

This report investigates major gastrointestinal (GI) bleeding, intracranial hemorrhage, and ischemic stroke events following new use of extended-release niacin and fenofibrates. 

Medical Product
extended-release (ER) niacin
fenofibrate
Health Outcome
gastrointestinal (GI) bleed
intracranial hemorrhage
ischemic stroke
Population / Cohort
Individuals 20-99 years of age
Time Period
January 1, 2007 - August 31, 2013
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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